China medical device sampling inspection results have recently been announced (No.53-2023) by the National Medical Products Administration (NMPA) on September 28, 2023. A total of 29 batches of medical device products, covering 14 different product categories, have been identified for not meeting the Chinese standard specifications. In this blog post, we will provide a detailed overview of the products and the respective regulatory measures reinforcing corrective actions to be carried out by the manufacturers.
Products not meeting standard specifications
According to the NMPA’s announcement on the sampling inspection results, the list of medical devices identified for not meeting the Chinese standard specifications are as followed:
- Soft Contact Lenses (2 batches): DUEBA Contact Lens and Vision Science Co., Ltd. produced lenses with non-compliant light transmittance and posterior focal lengths.
- Adhesive Medical Devices (9 batches): Products such as far-infrared therapy patches, magnetic therapy patches, and acupoint magnetic therapy patches from various manufacturers were found to contain drug components that exceeded permissible limits.
- Hemodialysis and Related Treatment Concentrates (2 batches): Concentrates produced by Nanjing Haibo Medical Device Co., Ltd. and Sanyuanfusheng Medical Device Co., Ltd. exceeded limits for endotoxins and microbial counts.
- Nd:YAG Laser Treatment Machine (1 unit): A machine from Jeisys Medical Inc. did not comply with standards for emergency laser terminators, key controllers, labeling, and laser pulse duration (pulse width).
- Ultrasound Bone Densitometer (1 unit): A product from Life Medical Equipment Co., Ltd. did not meet standards for speed of sound (SOS).
- Ultrasound Therapy Devices (2 units): Devices from Tianjin Ceragem Medical Device Co., Ltd. and Zhengzhou Aiboer Medical Equipment Co., Ltd. showed inaccuracies in output labeling and rated ultrasound output power.
- Electric Suction Apparatus (1 unit): A product from Liaoning Baihe Medical Equipment Co., Ltd. exhibited non-compliance in human error and suction tube specifications.
- Slit Lamp Microscopes (2 units): Products from C.S.O. SRL (Italy) and Chongqing Sunkingdom Medical Instrument Co., Ltd. did not meet standards for input power and microscope magnification tolerance.
- Biofeedback Treatment Device (1 unit): A product from Guangzhou Rianjet Medical Equipment Co., Ltd. did not comply with standards for continuous leakage current and patient-assisted current (at normal operating temperatures).
- Infusion Pumps (3 units): Products from Guangdong Wanzhong Technology Co., Ltd., Hou’ai Medical Instruments (Jiangsu) Co., Ltd., and Zhengzhou Lumai Medical Technology Co., Ltd. showed inaccuracies in indicator displays, audible alarm signals, and working data accuracy.
- Pressure Steam Sterilizer (1 unit): A product from Ningbo Kaipu Electronic Instrument and Meter Co., Ltd. did not comply with overcurrent protection standards.
- Dental Low-Speed Electric Motor (1 unit): A product from Foshan TEALTH Medical Equipment Co., Ltd. exhibited non-compliance with leakage current and patient-assisted current (at working temperatures).
- Cystatin C Assay Reagents (1 batch): A batch of reagents from Zhejiang Kangda Medical Technology Co., Ltd. did not meet accuracy standards.
- Homocysteine Assay Reagents (2 batches): Reagents from Anhui Tongzhi Biological Engineering Co., Ltd. and Yunnan Haoxu Biological Technology Co., Ltd. did not meet accuracy standards.
Actions taken by NMPA
The NMPA has taken swift action in response to these findings. Provincial drug regulatory authorities have been instructed to enforce administrative measures in accordance with regulations such as the “Regulations for the Supervision and Management of Medical Devices,” the “Measures for the Supervision and Management of the Production of Medical Devices,” and the “Measures for the Management of Medical Device Recalls.” These measures include public disclosure of administrative decisions.
Provincial authorities are also overseeing risk assessments conducted by companies with products that failed to meet standard specifications. The severity of the medical device defects determines the recall level. Companies are urged to initiate product recalls promptly, disclose recall information publicly, identify the causes of product non-compliance, develop corrective actions, and implement them within the specified timeframe.
Further information
Read the original announcement on the NMPA’s inspection results.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.
